Claudia Bach

ISO 14971 (2019) Released

If you haven’t heard by now, you should know that ISO-14971, Medical devices — Application of risk management to medical devices, has released its 3rd edition, which you can purchase here. We also offer a redline edition of the document available here.

14971 goes over the principles and processes for risk management specifically those pertaining to medical devices and in vitro diagnostic medical devices. Specifically, this will help you identify, control, and monitor the risks and effectiveness of the controls. For more details on the subject, I would suggest checking out our previous posts on the standards easily accessible here and here.

Companion Standard

ISO 24971 is also now available for purchase! It has been long awaited but it is finally made it out of committee review. You can grab your own copy here! Don’t for get to ask us about out subscription service.

So What’s New?

Aside from a few new terms and some format changes for accessibility, there a few fundamental changes made to the document. Some of these changes include as per the publisher:

a clause on normative references to respect requirements for fixed ISO/IEC directives
terms have been updated to match up with ISO/IEC Guide 63:2019
Definitions of certain terms such as benefit, state of the art have been added
More attention to the benefits of use of medical devices. Benefit-risk analysis has been aligned with terminology used in some regulations.
The process descruved can be used for managing risk
Requirements to disclose residual risks have been merged into one requirement
Results of reviews is now risk management report
Requirements for production and post production activities have been restructured and clarified.
Several annexes moved to guidance of ISO/TR 24971

If you would like a more detailed representation of the differences between editions, check out the redline edition available here. This is a great option if you want to easily see what was changed without having to spend any time comparing it with the older edition. Change are clearly marked for viability. Ordering redline editions will give you access to both marked and unmarked editions for convenience. You can find an unmarked edition here.

This document is part of our yearly subscription service, StandardsOnline. We make it easy for you and your team to access the same document without the hassle of buying multiple copies. If you would like to learn more about this service, go here.

Medical Device Regulation and a Hard Brexit

The U.K. Government released information today on Medical Device Regulation and a Hard Brexit. Here is the link to the relevant page: https://www.gov.uk/government/publications/further-guidance-note-on-the-regulation-of-medicines-medical-devices-and-clinical-trials-if-theres-no-brexit-deal/further-guidance-note-on-the-regulation-of-medicines-medical-devices-and-clinical-trials-if-theres-no-brexit-deal.

As noted before, the U.K. and BSI in particular are trying to keep a hard Brexit from negatively impacting public health and welfare. To this end, participation in EU standards activities and maintaining regulatory consistency short term are top priorities. I know many of our Document Center Inc. customers and other medical device manufacturers have been concerned. You will all appreciate this official information which provides the beginning of clarity on this worse-case scenario.

IoT Standards

I’ve been attending some of SAE International’s mobility meet-ups lately. These gatherings are focused on automated vehicles, of interest to many here in Silicon Valley. As I meet the other attendees, I often hear questions about the state of standardization with regards to IoT, the Internet of Things. So today I’m providing you with some information on IoT Standards.

IoT Standards actually cover a lot of ground. These documents provide the connectivity protocols for linking things to the network. A number of them have been in use for quite some time. However, the proliferation of devices that gain functionality when connected puts a strain on the standards process. In order to be universal, standards have to be developed in advance of implementation. This is the challenge that new technologies bring to our standards processes.

Consortia have often been used to develop standards in emerging technologies. They tend to be narrowly focused with an urgent need to reach agreement. One such group operating in this space is the Open Connectivity Foundation (OCF). Started as the UPnP Forum, this group has expanded it’s mission over time. They are also of particular interest as they have taken the standards they’ve developed and sent them up into the ISO/IEC system via JTC1 (the Joint Technical Committee 1).

An example of this is the series of IoT standards known as ISO/IEC 29341-30. These documents focus in on the UPnP functionality – Universal Plug and Play. They are used by many of you, essential for the many home networks for connectivity between devices. The OCF developed this series first and then used the ISO/IEC adoption protocol for publicly available specifications (PAS) to transform them into international standards.

Needless to say, there are many consortia working in this space. You’ll also find applicable standards activities happening in the traditional Internet standards spaces (IETF and WC3 for example). And of course, our more mainstream standards bodies are also busy working on new standards in this space (ETSI, ISO/IEC JTC1, IEEE and so on).

Here is a list of IoT standards that are currently available from ISO/IEC:

ISO/IEC 20922:2016
Information technology – Message Queuing Telemetry Transport (MQTT) v3.1.1
ISO/IEC 21823-1:2018 PRV
Internet of Things (IoT) – Interoperability for IoT systems – Part 1: Framework
ISO/IEC TR 22417:2017
Information technology – Internet of things (IoT) – IoT use cases
ISO/IEC 29161:2016
Information technology – Data structure – Unique identification for the Internet of Things
ISO/IEC TR 29181-9:2017
Information technology – Future Network – Problem statement and requirements – Part 9: Networking of everything
ISO/IEC 29341-30-1:2017
Information technology – UPnP Device Architecture – Part 30-1: IoT management and control device control protocol – IoT management and control architecture overview
ISO/IEC 29341-30-2:2017
Information technology – UPnP Device Architecture – Part 30-2: IoT management and control device control protocol – IoT management and control device
ISO/IEC 29341-30-10:2017
Information technology – UPnP Device Architecture – Part 30-10: IoT management and control device control protocol – Data store service
ISO/IEC 29341-30-11:2017
Information technology – UPnP Device Architecture – Part 30-11: IoT management and control device control protocol – IoT management and control data model service
ISO/IEC 29341-30-12:2017
Information technology – UPnP Device Architecture – Part 30-12: IoT management and control device control protocol – IoT management and control transport generic service
ISO/IEC 30118-1:2018
Information technology – Open Connectivity Foundation (OCF) Specification – Part 1: Core specification
ISO/IEC 30118-4:2018
Information technology – Open Connectivity Foundation (OCF) Specification – Part 4: Resource type specification
ISO/IEC 30118-5:2018
Information technology – Open Connectivity Foundation (OCF) Specification – Part 5: Smart home device specification
ISO/IEC 30141:2018
Internet of Things (IoT) – Reference architecture

You can see they are a mix of IoT standards that have been pushed up, like the ISO/IEC ISO/IEC 29341-30 series, and those that have been developed at the International level itself.

However, there is definitely a need for more standardization and consensus in this space. Since it is a hot area for product development, we can expect a mix of successful and failed standards. But as usual, the drive for development of protocols in advance of the investment required for new product will insure that this space will be very active for some time to come.

Should you need any of the above standards, Document Center Inc. is an authorized distributor for ISO and IEC. In addition, we can assist you with many of your standards challenges. Our standards collection consists of over 1 million documents. And since we have been working with standards since 1985, we have a depth of knowledge rare in this area. Contact us by phone (650-591-7600) or by email (info@document-center.com) for assistance. We are your Standards Experts!

BSI will remain in CEN/CENELEC after Brexit!

As you probably know, the future of the UK’s involvement in the European Standards system has been in question ever since Brexit became a reality. So I’m happy to let you know that BSI will remain in CEN/CENELEC after Brexit. We’ve known for some time that it would take a modification of the rules to allow for this. On November 23, 2018, a vote was taken. BSI will be able to remain a full member of both CEN and CENELEC, the European equivalents of ISO and IEC.

BSI had 8 areas of concern that led it to work towards a modification of the rules to allow it to stay involved in CEN/CENELEC should the U.K. withdraw from the European Community. Here’s the list:

Standards provide a passport to trade.
The European standards system has simplified the market structure in
Europe through the use of the single national standard model across
34 countries in the region.
The European standards system is neither owned by nor is it an
agency of the European Union.
The UK has significant influence in the development of European
standards.
Maintaining full UK membership of CEN and CENELEC is important
to the success of business in Europe post-Brexit.
Maintaining full CEN and CENELEC membership also brings benefits
to consumers and other public interest groups.
BSI must therefore continue as a full member of CEN and CENELEC
post-Brexit.
Standards will provide a key element underpinning future free trade
agreements between the UK and non-EU countries.

Apparently, until now the administrative rules governing CEN and CENELEC required membership in the European Union. This solution has needed a 100% in favor vote from the existing stakeholders. The positive outcome for BSI represents a political success as well as a pragmatic one.

How does this affect Document Center Inc. customers and other standards users? BS EN standards will remain valid for use when trading with the European Union. So any collection of BS EN standards used in your company can be left in place without worry.

Additionally, I would mention that at the recent ISO General Assembly in Geneva, there was much discussion of the role of standards and standardization in continuing the trend towards global free trade in spite of current political rhetoric. This vote within the European standards bodies reflects the desire of many in our community to foster larger global goals. After all, some of the most fundamental reasons for standards rest securely in the domain of public safety and well-being. This development will surely bring a sigh of relief to many.

BSI has a press release and earlier position paper you can review to learn more. If you have further questions, please get in touch with us. We can be reached at info@document-center.com or by phone at 650-591-7600. Should you want to review the status of any of your EN standards, please search on our website www.document-center.com. We track and sell over a million standards for you. As you can see, Document Center Inc. is committed not only to providing you with standards, but also the information you need to use your standards collection with confidence. Make us your Standards Experts!

What’s up with the new EN-IEC standards?

Lately some of the EN IEC adoptions have been renumbered as EN-IEC standards. Our Document Center customers are asking us why this change is being made. So when I was in Geneva Switzerland last month, this was one of the questions that I wanted answered by my European colleagues.

To my delight, Elena Santiago, the Director General of CEN and CENELEC, was a featured speaker at our IFAN (the International Federation of Standards Users) General Meeting. I had a chance to speak with her during a break. Of course, I had a number of questions for her, and one of them was about the new EN-IEC numbering.

Ms. Santiago explained that the new releases are the culmination of work begun a couple of years ago at the request of the CEN and CENELEC membership. The mandate is to bring the identical EN adoptions of the IEC standards into line with the protocol for the adoptions of the ISO standards. So the IEC adoptions are being reissued with a new number scheme that includes the IEC designation.

Why? “For traceability,” said Ms. Santiago. CEN and CENELEC members want the same clear acknowledgement of lineage that has always been a part of the ISO adoptions. So now when you see the EN-IEC standard designation, you know that you are looking at an identical EN adoption of the source IEC document.

Of course, I had more questions than this! One of them that’s getting a lot of attention from standards users in general is the issue of Brexit. Ms. Santiago not only discussed this with me, but also touched on it during her presentation. She is hopeful that during the CEN CENELEC meetings in November a vote can be taken to modify the membership rules of the organizations. With this change, the U.K. can continue to participate in and use the EN standards system.

I’m sure we’ll all be waiting to see how this particular story ends! Meantime, I’m glad to be able to shed some light on the new EN-IEC standards designation for you.

If you need to see if an EN standard you use is current and correct, please check in with our Document Center Sales Staff at info@document-center.com. Or call us at 650-591-7600. You can also look up any of the standards you use on our website, www.document-center.com. Any further questions, please ask. We’re here to help.

EN 71-1 has been amended – Safety of Toys

EN 71-1, Safety of toys – Part 1: Mechanical and physical properties, has just been amended. It is available now from Document Center Inc. in a number of national editions and formats. The complete current number is EN 71-1:2014+A1:2018. Adoption as a harmonized edition for Directive 2009/48/EC (Safety of Toys) is expected.

FYI: I reviewed the original 2014 Edition for this document in a previous EN 71-1 2014 Updated post.

Now for the important part for most of you – What are the changes? Well, first of all this is really the 3rd Amendment for the 2014 Edition. And there are a lot of clauses that have been changed. To see the complete list, review pages 11 and 12 of the European foreword. Some highlights include:

The addition of flying toys, toy slings, and toy catapults (with projectiles).
Requirements for projectiles (kinetic energy density principles, impact resistance, etc.)
Requirements for flying toys (includes rotors, propellers, etc.)
New requirements for leading parts (including suction cups)
New requirements for cords
Changes for toys attached to cradles, cots, or carriages (perambulators), including warnings
Changes to test methods for scooters

Remember, the EN 71-1 only covers hazards which are not obvious. You are responsible for things like the inherent instability of a 2 wheel scooter, etc. You also need to use caution should your product be one that is often given to children inappropriately (a game for older children, but given to younger ones too even though the box is marked for a specific age range). Luckily, parents and care-givers are still considered to have responsibilities when it comes to the use of toys by their children!

If you need this standard, or any in the EN 71 series, please get in touch with us. Here is a link to the order page for BS EN 71-1. Should you need additional assistance, please contact us by phone (650-591-7600) or email (info@document-center.com). We have been working with standards since 1985. Make us your Standards Experts!

ISO 19011 2018 Released!

ISO 19011 2018 has just been released. This standard is titled Guidelines for auditing management systems. It is the most widely used standard for ISO management system auditors.

I have blogged about this standard before when the 2nd Edition was released back in 2011. (See ISO 19011 2011 Edition.) This new 3rd Edition cancels and replaces that previous release. And it is considered a technical update.

One reason the management system standards are all being updated right now is in response to user requests for a consolidated approach to these many schemes. With this in mind, it should be obvious that auditors will have to adjust almost every system review to accommodate the new approach. And if your organization supports more than 1 such scheme, you’ll want to know how your reviews will be affected.

Luckily, the committee has given us a description of the main changes to the document in the Foreword. These include

A risk-based approach to the principles of auditing
More guidance on managing the audit program
More guidance on conducting the audit itself (especially the audit planning section)
Increased generic competence requirements for auditors themselves
Removal of the Annex on competence requirements for specific ISO management system standards (now too many to be practical)
Expansion of Annex A with guidance on auditing new concepts like virtual audits, compliance and supply chains, and so on.

You may very well have internal auditors in your organization. If so, you should consider purchasing this new edition of the ISO 19011. It will help you set up your training material. Certainly, it should be used for regulatory and other contractual reasons. And it can also be useful for those of you who self-declare when exporting your products.

Get a copy of this new 2018 Edition now from Document Center Inc. Here is the link to the order page for ISO 19011 for your convenience. If you have further questions, please don’t hesitate to get in touch. You’ll find that we not only sell standards, but we help you become a more effective user of standards. Make us your Standards Experts!

EN ISO 10993-11 2018 is here!

EN ISO 10993-11 2018 is here! It’s the European adoption of the ISO-10993-11 issued in 2017. The title of the standard is Biological evaluation of medical devices. Tests for systemic toxicity. While the 2009 Edition of this standard is still part of the harmonized lists for 2007/47/EC, 90/385/EEC, and 93/42/EEC, acceptance of this new 2018 edition is expected.

Changes in the standard reflect the changes in the ISO 10993-11 from 2017. Here is a list of the guidance on them provided by ISO:

Reduction in the group size for chronic toxicity testing (see Table 1)
Annex F has been renamed Annex G and a new Annex F has been added
Annex H was also added
the Bibliography was updated.

Toxicity testing provides evidence that a medical device is safe to use for its intended purpose. This standard provides you with a framework for conducting a systemic toxicity study.

For this article, I reviewed the BS EN ISO 10993-11 2018 Edition. Although the European standard references the ZA and ZB Annexes, I don’t find them in this publication. We may be soon seeing an update to this particular national edition, as the European Annexes provide detailed information on how the standard relates to the 3 medical device directives.

Remember, you do have choices when you purchase EN standards. The official text is the basis for all national editions. So you can get the copy that meets your needs the best. If you have questions on which to purchase, just get in touch with our staff. We can be reached by phone (650-591-7600) or email (info@document-center.com). Make Document Center Inc. your Standards Experts!

ISO 10045 2nd Edition released – Alpine Skis

Are you going to the snow for the winter holidays? Guess what! Standards are going to be there with you if you enjoy many winter sports. So let’s take a look today at the new 2nd Edition for ISO 10045. It’s titled Alpine skis – Binding mounting area – Requirements for test screws. This standard has not been revised since the release of the 1st Edition back in 1991. It’s a technical update.

What exactly is the ISO 10045 about? It’s a set of requirements for the use of test screws. These screws are used for testing the binding mounting area of alpine skis. The standard makes sure the measurement data can be uniformly compared. It does this by specifying the dimensions, mechanical properties, and fastening characteristics of the test screws.

The 12 page standard actually has 4 pages of technical material. These include the usual scope, referenced documents and definition sections. Section 4 is on designation. The various requirements, including materials, dimensions, strength, and characteristics like mounting and fastening are covered in Section 5. The text is supported by a figure of the test screw itself, showing dimensions, etc.

To get your copy, please head to the Document Center Inc. webstore at www.document-center.com. We are an authorized distributor of the ISO standards and have been working with these documents since 1982. Here is a direct link to the order page for ISO 10045 for your convenience.

Need obsolete editions? Want more delivery options? Have questions about how to properly use standards? Get in touch with our staff to get the personalized attention that Document Center Inc. is known for. You can reach us by phone (650-591-7600) and email (info@document-center.com).

Standards are an essential part of most sports equipment. If you have any products and want to learn more about the standards that support safety and interconnectivity, let us know. We’re your Standards Experts!

ASTM F2413 updated for Safety Toe Shoes

ASTM F2413, Standard Specification for Performance Requirements for Protective (Safety) Toe Cap Footwear, has been updated. The new 2017 Edition replaces the previous 2011 Edition, which is now obsolete. I reviewed the previous edition in my September 1, 2011 Post on the ASTM F2412 and ASTM F2413. This is an extensive, technical update to this important foot-safety standard.

The ASTM F2412 and ASTM F2413 replace the ANSI Z41 that was used for over 60 years. Together, they provide the performance criteria for protective footwear. These standards play an important role in worker safety in many industries.

The ASTM F2413 itself is on minimum requirements for the performance of shoes that protect against a number of workplace hazards. This is accomplished by evaluation of shoes for impact and compression resistance, particularly in the toe area, other foot protection, and protection against electrical hazards.

Once you believe that your shoe meets the ASTM requirements, you’ll take samples to an authorized testing lab for verification. If the shoe passes the various tests, the ASTM label can be printed on your footwear. Guidelines for the labeling and other identifications are included in the standard.

Changes are extensive and occur throughout the document. You can find them all in the redline edition available from Document Center Inc. We are an authorized distributor of the ASTM standards. You can search for and order them from our webstore at www.document-center.com. Here is a direct link to the order page for ASTM F2413 for your convenience. Let us know if you’d like the redline edition or if you need company-wide cloud access to the standard.

We have a number of support services to help your compliance needs for documentation for your organization. Learn more by reaching out to our staff by phone (650-591-7600) or email (info@document-center.com). We have been selling standards since 1982. Learn why so many folks make us their Standards Experts!